Please join us for a 30-minute webinar in which we discuss a case study of a leading pharma company who automated their quality agreement and CRO oversight plan to meet imminent ICH E6 (R2) requirements.     
 
Date: Wednesday, March 15, 2017
Time: 10am PST (1pm EST)
Duration: 30 minutes
  

The CRO Oversight Plan is a guideline for the ClinOps team to ensure the vendor’s adherence to the Scope of Work (SOW), study-specific plans, processes, procedures, and GCP guidelines.  The development of a Quality Agreement and Oversight Plan documents the frequency and process for:

  • KPI Definition
  • Calculations
  • Thresholds
  • KPI Monitoring
  • Issue Management
  • Escalation
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In the brief 30 minutes, we will cover how a leading sponsor develops and automates a Quality Agreement and CRO Oversight Plan to enable ClinOps teams to proactively monitor and ensure a risk based approach to oversight.
 

Featured Speakers:

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Julie Peacock, Clinical Intelligence Expert, Comprehend

Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go to market strategy, sales enablement, and product marketing.

Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space where she managed strategy, field enablement and launch activities for a series of BtoB solutions. Julie holds a bachelor’s degree in Marketing from Auburn University.